在便携式弹性体输液器件中Ceftobiprole Medocaril的稳定性
Beatriz Esteban-Cartelle1,2, Brayan J Anaya1, Covadonga Pérez Menéndez-Conde2
1Department of Pharmaceutics and Food Technology, School of Pharmacy, Complutense University of Madrid, Plaza Ramón y Cajal, 28040, Madrid, Spain.
Infectious diseases and therapy
|July 2, 2025
概括
在室温的盐溶液中,Ceftobiprole美多卡里尔稳定24小时,用于门诊亲肠道抗菌药物治疗 (OPAT). 这种新型抗生素适用于家用便携式输液装置,药物损失最小.
科学领域:
- 制药科学 制药科学
- 传染性疾病 传染性疾病
- 临床药房 临床药房
背景情况:
- 塞夫托比普罗尔 (Ceftobiprole medocaril) 是第五代塞法洛斯波林前药物,在门诊亲肠道抗菌疗法 (OPAT) 中,其物理化学稳定性数据有限.
- 通过OPAT,可以在家用便携式弹性体输液装置进行静脉注射抗生素.
- 在这些设备中评估 ceftobiprole medocaril 的稳定性对于安全有效的门诊治疗至关重要.
研究的目的:
- 在OPAT的便携式弹性体输液装置中确定 ceftobiprole medocaril 的物理化学稳定性.
- 为了评估药物的稳定性在不同的输液液体和温度相关的家庭管理.
主要方法:
- 在0.9%的化和5%的乳糖中制备了Ceftobiprole美多卡里尔溶液 (6.25 mg/mL).
- 物理化学稳定性在2-8°C,25°C和32°C时使用LC-QQQ-MS进行评估.
- 量化了对弹性体器件壁的药物吸附.
主要成果:
- 在0.9%的化中24小时在2-8°C和25°C下保持>95%的稳定性.
- 在5%的乳糖溶液中,稳定性降低.
- 观察到装置中药物吸附率微不足道 (<0.1%);pH值保持在可接受的范围内,并且没有形成颗粒.
结论:
- 塞夫托比普罗尔美多卡里尔 (6.25 mg/mL在0.9%的化中) 适合在25°C下使用在OPAT中的Accufuser®弹性体输液装置进行24小时的给药.
- 这些发现支持在家中使用 ceftobiprole medocaril 治疗时制定实用管理方案.
- 该研究证实了这些设备适合于安全有效的外科医生使用 ceftobiprole medocaril.
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